AstraZeneca’s Dapagliflozin receives CDSCO approval with additional indication for treatment of patients with Chronic Kidney Disease and Heart Failure

AstraZeneca India announced that the company has received the Central Drugs Standard Control Organization’s (CDCSCO) approval for their anti-diabetic drug Dapagliflozin in the treatment of adults with chronic kidney disease (CKD). Dapagliflozin is the first and only anti-diabetic drug approved to significantly reduce the risk of sustained eGFR (estimated Glomerular Filtration Rate), cardiovascular deaths and hospitalizations due to heart failure in adults with progressive chronic kidney disease. This approval is applicable for both diabetic and non-diabetic CKD patients.

The approval is based on the consistent results from the DAPA-CKD study, where the indication has now been recommended in adults with Chronic Kidney Disease, up to an eGFR greater than or equal to 25 ml per min per 1.73 m2. Below this, the initiation is currently not recommended, however patients may continue with their daily dose of 10mg orally to reduce the risk of eGFR decline, End Stage Kidney Disease (ESKD), cardiovascular deaths and heart failures. Earlier only up to CKD stage 3 patients could be initiated Dapagliflozin but with this approval physicians can initiate Dapagliflozin for a subset of CKD stage 4.

Chronic kidney disease (CKD) is one of the leading causes of hospitalization globally and in India, representing a significant clinical and economic burden. CKD is progressive disease and continues to be the major cause of morbidity and mortality, with adverse outcomes of kidney failure and premature death. The prevalence of CKD in India is estimated to be 17.2% and nearly 10 Mn patients may be on stage 4 CKD. AstraZeneca’s Dapagliflozin is an oral anti-diabetes drug which has shown increasing benefits in not only preventing heart failure but also in managing chronic kidney disease and Heart failure with reduced ejection fraction irrespective of Diabetes status

Speaking on the occasion, Dr. Anil Kukreja, Vice President – Medical Affairs and Regulatory, AstraZeneca India said, “The timely approval of Dapagliflozin from the CDCSCO committee with the additional indication is a huge boost for nephrologists across the country towards the management of progressive Chronic Kidney Disease. At AstraZeneca, we are committed to constantly push the boundaries of science and technology to address the unmet need of heart failures and CKDs globally. Today, there is a paradigm shift in the usage of leading diabetic drugs for a wider scope and we see huge potential for this segment. The approval will provide the clinical community with a potential therapeutic option to arrest the progression of CKDs and address heart failures at an early stage.”

Collaboration is the key to accelerating change, creating patient-centric approaches and to reverse and cure diseases within the CVRM spectrum by reimagining patient care. Under the theme of ‘Kidney Health For All’, AstraZeneca has facilitated ‘Project SEARCH’ – a mass screening program for the early diagnosis of CKD in diabetic or hypertensive patients who are at high risk of kidney damage. Through the Chronic Kidney Disease Academy, for holistic management of kidney diseases, we facilitate education of the clinicians about the prevention, progression and management of chronic kidney diseases, AstraZeneca aims to reduce the associated mortality and morbidity rate in India.

Dr. Shyam Bihari Bansal, Director, Nephropathy and Kidney Transplantation, Medanta – Medicity, Gurgaon said, “Dapagliflozin, an SGLT2 inhibitor, has been a breakthrough in managing CKD. This is helpful for both diabetic and non-diabetic CKD patients. Its approval by the regulatory bodies in India is a welcome move, with the revised eGFR cut-off coming down to 25ml/min/1.73 m2. This will enable Nephrologists to initiate Dapagliflozin to more eligible patients, thus slowing the deterioration of kidney function, delaying dialysis, and saving more lives. Unfortunately, most of the patients are diagnosed at a late stage of CKD, therefore, physicians who are treating the risk factors such as Diabetes, Hypertension etc. can play a pivotal role in diagnosing CKD early and reducing renal failure by initiating these drugs at an early stage.”

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